FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79705–79728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2001
ANCURE LLIAC BALLOON CATHETER
K003495 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 86d
Cleared Feb 07, 2001
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
K003533 · JOJ
Steritec Products, Inc.
General Hospital · 83d
Cleared Feb 07, 2001
ADAPTERS WITH X-COATING
K003604 · DTL
Terumo Cardiovascular Systems Corp.
Cardiovascular · 78d
Cleared Feb 07, 2001
THERMOFX MESH
K003757 · JEY
Bionx Implants, Ltd.
Dental · 63d
Cleared Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K010064 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 07, 2001
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
K010130 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 22d
Cleared Feb 06, 2001
EXCITE DSC
K003293 · KLE
Ivoclar North America, Inc.
Dental · 109d
Cleared Feb 06, 2001
PALMLIGHT
K003383 · EBZ
Ultradent Products, Inc.
Dental · 98d
Cleared Feb 06, 2001
TAI-CHI ACUPUNCTURE NEEDLES
K003760 · MQX
Lhasa Medical, Inc.
General Hospital · 62d
Cleared Feb 06, 2001
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
K003958 · FZP
Coalescent Surgical
General & Plastic Surgery · 47d
Cleared Feb 06, 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT...
K004048 · LYY
Tillotson Healthcare Corp.
General Hospital · 39d
Cleared Feb 06, 2001
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+,...
K010238 · FLL
Actherm, Inc.
General Hospital · 12d
Cleared Feb 06, 2001
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
K010247 · LZA
Shanghai China Star Corp
General Hospital · 11d
Cleared Feb 05, 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781 · OLX
Neurosoft, Inc.
Neurology · 237d
Cleared Feb 05, 2001
MODULAR
K001988 · BSZ
Heyer America, Inc.
Anesthesiology · 221d
Cleared Feb 05, 2001
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
K002201 · CAH
Sims Portex, Inc.
General Hospital · 200d
Cleared Feb 05, 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280 · MKJ
Medical Devices, Inc.
Cardiovascular · 194d
Cleared Feb 05, 2001
RANDOX TRANSFERRIN
K002585 · DDG
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Feb 05, 2001
MINIQUANT D-DIMER, MODEL 1447
K002642 · DAP
Biopool Intl., Inc.
Hematology · 165d
Cleared Feb 05, 2001
MICTEC ENDOSCOPES AND ACCESSORIES
K002877 · GEI
Dufner Instrumente GmbH
General & Plastic Surgery · 143d
Cleared Feb 05, 2001
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
K003478 · LPH
Zimmer, Inc.
Orthopedic · 88d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · LPS
Diagnostic Products Corp.
Toxicology · 76d
Cleared Feb 05, 2001
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY...
K003704 · BZQ
Optovent AB
Anesthesiology · 66d